With the increasing demand for research opportunities, Lahey Hospital & Medical Center realized the inherent need to create one centralized office comprised of professional medical staff solely dedicated to clinical trials. In 1994, The Office of Research Administration (ORA) was established. The ORA continues expansion into widening areas of medical research.
Lahey’s ORA serves as a central resource to encourage, facilitate, support and oversee research with expert staff dedicated to ensuring compliance with federal regulations, sponsor requirements, and clinic policies. ORA works closely with Lahey Hospital & Medical Center’s Institutional Review Board (IRB) to review and monitor any human subject research taking place at LHMC.
Research Administration is comprised of a diverse group of experienced administrative and clinical professionals consisting of:
- Research Director
- IRB coordinators
- Agenda coordinators
- Research study coordinators
- Clinical research associates
- Clinical research specialists
- Research administrative assistants
- Quality Analysts
- Financial analysts
Investigators, study coordinators, clinical research associates and regulatory associates attend comprehensive training. Training involves review of proper management of clinical studies, Good Clinical Practice (GCP’s), participant safety, maintenance of study data, regulatory forms, completion of case report forms (CRF’s) and research quality assurance. All investigators and research staff participating in clinical trials must complete a research study session that includes Lahey-sponsored education and the CITI Research program with certification renewals every three years. Staff is encouraged to attend workshops and training as part of continual education.
Lahey Hospital & Medical Center Institutional Review Board (IRB) reviews and monitors any research taking place at Lahey Hospital & Medical Center that involves human subjects.
The primary responsibility of the IRB is to protect the rights and welfare of research subjects. The IRB follows rules that are defined in the United States Code of Federal Regulations.
The Lahey IRB is composed of a diverse combination of Lahey Hospital & Medical Center colleagues together with lay members from the community. The board meets as a full committee on the second Wednesday of each month. At these meetings, the committee reviews applications that require Full Board Review. For time-sensitive protocol reviews, a Secondary IRB will meet within 10 working days at the request of an investigator. Some submissions qualify for review by a single IRB member, through an expedited process; these submissions are reviewed on a weekly basis.
In 2013 Lahey IRB implemented the use of IRBNet for all IRB correspondence.
If you have questions about the Lahey IRB or about your rights as a research subject, please contact the Office of Research Administration at 781-744-8027.
For more information on Research Administration and complete services provided, please contact the Office of Research Administration at 781-744-8027.
Meet The Team
The ORA serves as a central resource to encourage, facilitate, support and oversee research with expert staff dedicated to ensuring compliance with federal regulations, sponsor requirements, and hospital policies. Lahey’s ORA is comprised of a diverse group of experienced administrative and clinical professionals consisting of IRB Administrators, Research Study Coordinators, Clinical Research Associates and Specialists, Research Administrative Assistants, Research Financial Analysts and a Quality and Audit team.
IRB Administrators work closely with Lahey Hospital & Medical Center’s Institutional Review Board (IRB) to review and monitor human subject research taking place at Lahey Hospital & Medical Center. In 2016 ~1300 submissions were made to the IRB. This averages about 100 submissions a month that need to be reviewed, corrected and processed for IRB committee approval. With ~300 ongoing clinical trials at any given time and 1000 new patients consented annually, the IRB administrators perform under tight deadlines all the while ensuring that all research is in compliance with state and federal regulations and clinic policies.
The Research Finance team is responsible for negotiating the budgets and contracts for all sponsored research studies. This complex task includes assuring appropriate legal review of study documents, as well as reviewing all agreements for compliance with institutional and regulatory policies. Additionally this team oversees research patient billing and federal grants management.
When the work of the IRB and finance groups are complete the Research Study Coordinators, Clinical Research Associates and Clinical Research Specialists take over. This group represents the face of research at Lahey interacting with research study subjects and ensuring that their day to day experience is the best it can be. Their duties include explaining research studies to new patients, following patients during their study participation and making sure that the study protocol is followed.
Finally, the Research Quality team provides general quality oversight to clinical trials conducted at Lahey Hospital & Medical Center and its affiliated sites. This team not only identifies and addresses quality and compliance issues with research throughout our institution, but also provides education and reference materials, support and training to all Lahey colleagues engaged in clinical research activities.
For more information on Research Administration and the services provided, please call our office at 781-744-8027.